BEUDAMED
    FDA Adverse Event Death Summary report: N

    MUGARD ORAL RINSE 240ML/BTL

    MDR report key: 17957361 · Received October 17, 2023

    Report

    Report Number
    MW5147065
    Event Type
    Death
    Date Received
    October 17, 2023
    Report Date
    October 12, 2023
    Manufacturer
    SOLEVA PHARMA LLC
    Product Code
    MGQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CAREGIVER (B)(6) REPORTED THAT THE PT HAS PASSED AWAY ON (B)(6) 2023. SWISH AND EXPEL OR SWALLOW 5 TO 10 ML 4 TO 6 TIMES DAILY AS PRESCRIBED FOR MANAGEMENT OF ORAL MUCOSITIS. PRESCRIBER CONTACT INFO: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539535 MUGARD ORAL RINSE 240ML/BTL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC MGQ SOLEVA PHARMA LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death